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Japan’s PMDA Fastest at Reviewing New Drug Approvals

In November 2016, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) reported that it has achieved the fastest median review time for new drug approvals in 2014 and 2015 among five other major regulators (US, Canada, Australia, Europe, Switzerland). In 2015, the median approval time for the PMDA was 284 days, in comparison to 351 in the US, 355 days in Canada, 373 days in Australia, 417 days in Europe, and 464 days in Switzerland. Previously, the PMDA was the slowest among these six regulators. PMDA Chief Executive Tatsuya Kondo credits its newfound success to the ability of officials to hold thorough discussions during pre-application consultations, eliminating the need for further exchanges during the review process. Despite this increased speed for approval, there are still many Western drugs (especially in cancer) that have never been registered in Japan.